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Karl storz se & co. Kg devices

Official notice

11 Apr 2022

Last checked

11 Apr 2022

Medium riskHealth Canada

An official Health Canada notice concerns Karl storz se & co. Kg devices. This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of reprocessing. Customers that do not have access to an appropriate sterilization method recommended in the applicable instructions for use for these endoscopes should discontinue use of the endoscopes and return them to Karl Storz as described. Recall start date: Apr 6, 2022 Published 2022-04-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64075

Official notice

2022-04-11

The hazard

This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of reprocessing. Customers that do not have access to an appropriate sterilization method recommended in the applicable instructions for use for these endoscopes should discontinue use of the endoscopes and return them to Karl Storz as described. Recall start date: Apr 6, 2022

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64075

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Affected products

Product 1

Affected Products - Flexible Digital Video Cystoscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11272VNU, 11272VN

Product 2

Affected Products - Flexible Video Cystoscope Hd-View, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11272VH-TL, 11272VHU-TL

Product 3

Affected Products - Broncho Fiberscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11005BC1

Product 4

Affected Products - Ureteroscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11278AC1, 11278AC2, 11278ACU1

Product 5

Affected Products - Flexible Pediatric Cystoscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11274BCU1

Product 6

Affected Products - Rhin0-Laryngo Fiberscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11001RD1

Product 7

Affected Products - Flexible Uretero-Reno Fiberscope, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11278A2, 11278AU1

Risk / hazard

This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of reprocessing. Customers that do not have access to an appropriate sterilization method recommended in the applicable instructions for use for these endoscopes should discontinue use of the endoscopes and return them to Karl Storz as described. Recall start date: Apr 6, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Karl Storz Se Kg, Karl Storz Se Kg Devices.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64075

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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